Ivacaftor

Pediatric Medication

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Brand Names: US

Brand Names: Canada

What is this drug used for?

It is used to treat cystic fibrosis.

What do I need to tell the doctor BEFORE my child takes this drug?

All products:

If your child has an allergy to this drug or any part of this drug.

If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

If your child is taking any of these drugs: Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, or St. John’s wort.

Granules:

If your child is younger than 12 months old. Do not give this drug to a child younger than 12 months old.

This is not a list of all drugs or health problems that interact with this drug.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

All products:

Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.

Have blood work checked as you have been told by the doctor. Talk with the doctor.

Have your child’s lung function checked as you have been told by the doctor. Talk with the doctor.

Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.

Avoid giving your child grapefruit and grapefruit juice.

Avoid giving your child Seville oranges.

Cataracts have happened in children taking this drug. Be sure your child has an eye exam before starting this drug and while taking it. Talk with the doctor.

This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.

If your child is pregnant or breast-feeding a baby:

Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.

Tablets:

Talk with the doctor before you give this drug to a child younger than 6 years old.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.

Change in eyesight.

Chest pain.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

Headache.

Dizziness.

Sore throat.

Nose and throat irritation.

Runny nose.

Stuffy nose.

Diarrhea.

Belly pain.

Upset stomach.

Pimples (acne).

Muscle or joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

All products:

To gain the most benefit, do not miss giving your child doses.

Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.

Mix the contents of the packet with 1 teaspoon (5 mL) of soft food or liquid. This includes pureed fruits or vegetables, yogurt, applesauce, water, milk, or juice. Food or liquid needs to be at or below room temperature.

Give this drug within 1 hour of mixing.

Give this drug just before or just after fatty foods. This includes eggs; butter; peanut butter; cheese pizza; or whole-milk dairy products like whole-milk, cheese, or yogurt.

What do I do if my child misses a dose?

Give a missed dose as soon as you think about it.

If it has been 6 hours or more since the missed dose, skip the missed dose and go back to your child’s normal time.

Do not take 2 doses at the same time or extra doses.

If you are not sure what to do if you miss giving your child a dose, call the doctor.

How do I store and/or throw out this drug?

Store at room temperature.

Store in a dry place. Do not store in a bathroom.

Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.

Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.

Do not share your child’s drug with others and do not give anyone else’s drug to your child.

Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.

Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Last Reviewed Date

Copyright

If you have any questions or concerns, contact a member of your healthcare team directly or call 212-639-2000 for help.

If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.